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Siapartners

Clinical Pharmacology and Pharmacometrics Lead-Contract- (12 Months)

Siapartners, Elkridge, Maryland, United States, 21075


Clinical Pharmacology and Pharmacometrics Lead-Contract- (12 Months)

ContractSia Partners is a next-generation management consulting firm. We offer a unique blend of AI and design capabilities, augmenting traditional consulting to deliver superior value to our clients. Counting 3,000 consultants in 19 countries, we expect to achieve $420 million in revenue for the current fiscal year. With a global footprint and expertise in more than 30 sectors and services, we optimize client projects worldwide.Contract roles are geared toward independent professionals interested in temporary or project-based work.Project Title:

Clinical Pharmacology and Pharmacometrics LeadLevel:

Mid-SeniorProject Length:

This is a temporary position with an expected duration of 12 months (with potential extension)Project Hours:

40 hours per weekLocation:

RemoteThe expected compensation range for this contract is $205k to $265k per year. The exact pay rate will vary depending on a wide array of factors, which may include but are not limited to skills, experience, and location.Key Responsibilities:

One of our premier clients is seeking a Clinical Pharmacology and Pharmacometrics Lead. This contractor will be reporting to the Head of Clinical Pharmacology and Pharmacometrics (CP&P). The Clinical Pharmacology and Pharmacometrics Lead (CP&P Lead) will lead the development of computational approaches to address high priority project development efforts at the Institute. The CP&P Lead will work with project teams to implement and communicate model-informed drug development strategies, to enable and accelerate internal decisions.Responsibilities include but are not limited to:Provide strategic leadership in Clinical Pharmacology and Pharmacometrics for both late-stage and early-stage assets, particularly in infectious diseases with focus on Tuberculosis and Malaria.Develop advanced models of drug exposure, exposure-biomarker response, and disease progression to facilitate informed drug development decisions.Collaborate extensively with internal and external stakeholders across various therapeutic areas, offering expertise in modeling, data science, visualization, and data analytics.Act as a Study Director and Clinical PK Scientist for infectious diseases programs.Contribute to regulatory documents related to Clinical Pharmacology, draft sections for clinical development plans, and engage in regulatory interactions.Assess the feasibility of clinical studies, providing critical input on the design and review of clinical protocols.Execute and manage Pharmacometrics and Modeling & Simulation (M&S) plans, interpreting and reporting results to support clinical development milestones.Integrate data from various compounds across development programs to inform strategic portfolio decisions.Represent the department in cross-functional teams, proactively addressing development opportunities.Lead cross-functional teams covering multiple assets, mentor junior Clinical Pharmacology scientists, and promote a culture of scientific excellence and innovation.Handle both small molecules and biologics programs effectively.Support project milestones in discovery and development phases using mathematical modeling and simulation tools, including PK/PK-PD, drug-drug interaction evaluation, PBPK-based dose/exposure scaling, QSP, and formulation/PK assessment.Demonstrate proficiency in Model-Informed Drug Development (MIDD), applying principles to ensure clear and timely communication of modeling results, thereby enhancing decision-making.Utilize advanced data analysis techniques and develop algorithms to detect patterns and associations in data, leveraging diverse datasets to inform models relevant to disease biology.Minimum Qualifications:PhD in engineering, math, computer science, pharmaceutical sciences or a related quantitative fieldMinimum of 10 years experience working in a quantitative discipline, with demonstrated impact in PK-PD, QSP, PBPK, disease progression, DMPK modeling.Advanced/Proficient high performance computing skillsExcellent communication and written skills, distilling complex technical ideas clearly and succinctly to a diverse audience.Ability to multi-task and manage through competing priorities in a fast-paced environmentStrong interpersonal, communication, organizational, administrative and customer service skills.Ability to work independently and collaborate within a team environment.Strong attention to detail and high sense of urgencyDemonstrated ability of leveraging self-initiative to get resultsStrong analytical, organizational and auditing skills requiredDemonstrated passion for the Gates MRI’s values with a commitment to deliver results against our mission.Expertise in developing and applying PK, PBPB, and PKPD models using software such as Matlab, R, NONMEM, Monolix, SimCYP, PK-SIM, GastroPlus, Phoenix, and R-Stan.Experienced in designing, implementing, and maintaining a GXP-validated high-performance pharmacometrics scientific computational environment.Experienced in compiling and optimizing diverse data sets from both clinical and non-clinical sources to enhance Model-Informed Drug Development (MIDD) efficiency.At this time, Sia Partners does not intend to pursue employment with applicants who will require now or in the future visa sponsorship by our company for work authorization in the United States (i.e., H1-B visa, F-1 visa (OPT), TN visa, or any other non-immigrant status).Our Commitment to DiversityDiversity, equity, inclusion, and belonging (DEIB) are part of Sia Partners’ DNA. Thanks to our expertise in several sectors and our international growth, our teams include a variety of experiences and cultures. We’re confident that promoting DEIB creates an environment in which everyone can reach their full potential.Sia Partners is an equal opportunity employer. All aspects of employment, including hiring, promotion, remuneration, or discipline, are based solely on performance, competence, conduct, or business needs.

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